ESMO Congress 2026

We have made considerable progress with Her2 targeting, especially in the first line, our Dr. Jaffer Ajani shared at #AACR26. Zanidatamab...

This is a breaking report from AACR, one of the world's largest cancer research conferences. The anti-HER2 bispecific antibody zanidatama...

HERIZON-GEA-01 Phase 3: Zanidatamab Plus Tislelizumab and Chemotherapy Lifts Median OS to 27.0 Months in First-Line HER2-Positive Advanced Gastric Cancer

In the HERIZON-GEA-01 study, the zanidatamab plus tislelizumab plus chemotherapy arm achieved a median overall survival of 27.0 months in HER2-positive advanced gastroesophageal adenocarcinoma, with HR=0.65. The global multicenter phase 3 trial reported this second interim OS analysis after a median follow-up of 35.3 months; median OS was 19.6 months in the control arm and 22.9 months in the zanidatamab plus chemotherapy arm, HR=0.76, P=0.0088.

BeiGene HERIZON-GEA-01: Zanidatamab Plus Tislelizumab and Chemo Extends OS in HER2-Positive Gastroesophageal Adenocarcinoma, Difference Versus Zanidatamab Plus Chemo Not Significant

In the Phase 3 HERIZON-GEA-01 trial from BeiGene, zanidatamab combined with tislelizumab and chemotherapy as first-line treatment for HER2-positive gastroesophageal adenocarcinoma achieved a median overall survival of 27.0 months. The difference versus the zanidatamab plus chemotherapy group did not reach statistical significance.

FDA approves Ziihera for first-line HER2-positive gastroesophageal adenocarcinoma, triggering milestones and $250 million Royalty Pharma financing

The FDA on August 25, 2026 approved Ziihera (zanidatamab-hrii) for first-line unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma: IHC 3+ and IHC 2+/ISH+ patients can receive it with tislelizumab plus chemotherapy, and IHC 3+ patients with chemotherapy alone. Under the BeOne Medicines collaboration, Zymeworks has received $81 million, with up to $144 million in further milestones and tiered royalties of up to 19.5%. The approval triggers the structure set up on March 2, 2026, when Zymeworks BC moved 30% of future Ziihera royalties into Zymeworks Royalty Limited Partnership, which borrowed $250 million in non-recourse notes from Royalty Pharma secured solely on those royalties.

FDA Approves Zanidatamab Combination as First-Line Treatment for HER2-Positive Gastroesophageal Adenocarcinoma

On August 25, 2026, the FDA approved the HER2 bispecific antibody zanidatamab for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma confirmed by an FDA-approved test. One approval covers zanidatamab combined with tislelizumab plus fluoropyrimidine and platinum chemotherapy for patients with HER2-positive disease defined as IHC 3+ or IHC 2+/ISH+. The approvals were based on the HERIZON-GEA-01 study.

FDA approves BeiGene tislelizumab with zanidatamab and chemotherapy for first-line HER2-positive gastroesophageal adenocarcinoma

The US FDA approved a new indication for tislelizumab on August 26, 2026, combining it with zanidatamab plus chemotherapy as first-line treatment for HER2-positive gastroesophageal adenocarcinoma (GEA). The approval covers patients regardless of PD-L1 expression and is the first approved regimen pairing a HER2 bispecific antibody with a PD-1 inhibitor. It rests on the HERIZON-GEA-01 trial, published in the New England Journal of Medicine and presented orally at the 2026 ASCO annual meeting.

FDA Approves BeiGene's Tevimbra Plus Zanidatamab and Chemotherapy for First-Line HER2-Positive GEA

The FDA has approved BeiGene's supplemental application for Tevimbra (tislelizumab) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma (GEA). About 20% of GEA patients are HER2-positive, a subtype that has long been difficult to treat.

FDA Approves Tislelizumab Plus Zanidatamab and Chemo for First-Line HER2-Positive Gastroesophageal Adenocarcinoma

BeiGene said the FDA has approved a supplemental application for its PD-1 antibody tislelizumab (BaiZeAn) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma. Results were published earlier this year in the New England Journal of Medicine. The material cites five-year survival below 30 percent for gastric cancer and about 19 percent for esophageal adenocarcinoma.

FDA approves Ziihera plus tislelizumab regimens for first-line HER2-positive gastroesophageal adenocarcinoma

The US FDA approved two first-line treatment regimens combining Jazz Pharmaceuticals' HER2 bispecific antibody Ziihera (zanidatamab-hrii) with tislelizumab, a PD-1 antibody originally developed by BeiGene, on August 25. The approval adds tislelizumab to first-line combination treatment for HER2-positive gastroesophageal adenocarcinoma in the United States. The approval covers two distinct Ziihera-based regimens.